Clinical trial

MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease

Opening soon · Not applicable · 1 countries · Registry ID NCT07478653

Opening soonNot applicableInterventional

What this study is about

The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question\[s\] it aims to answer \[is/are\]: if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone. Participants will receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Dental Care for Children

Full registry criteria

Inclusion Criteria: * participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389) * Class 2 or 3 obesity (BMI =120% of the 95th percentile for age and sex) Exclusion Criteria: * Same exclusion as parent study. * Planning to receive or complete dental services during the 12-month course of the study * Ongoing orthodontic treatment * Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment * Currently taking medications that could influence the characteristics or response to periodontal treatment (e.g., use of immunosuppressants or steroids) * Local or systemic antibiotic use within 15 days prior to enrollment or for \>10 days within the past 3 months * History of bleeding disorders * Professional dental prophylaxis or non-surgical periodontal therapy within the past 6 months

Treatments and study arms

Dental Cleaning and Oral Hygiene Instruction (OHI)

Procedure

Participants receive dental cleaning and oral hygiene instruction (OHI) and oral health assessments at baseline (prior to initiating weight-loss medication), 6 months (±2 weeks), and 12 months (±1 month) post-enrollment.

Oral Hygiene Instruction (OHI)

Behavioral

Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.

Primary outcomes

Change in gingival indexBaseline, 6 months, 12 months

Based on visual assessment and gentle probing of the marginal periodontal tissues. Scored on a 0-3 scale and the higher score means increased inflammation.

Change in probing depthBaseline, 6 months, 12 months

Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.

Change in BOP (Bleeding on probing)Baseline, 6 months, 12 months

Presence or absence of bleeding upon probing recorded at six sites per tooth.

Change in Plaque IndexBaseline, 6 months, 12 months

Measured using a plaque score (0-3) at six specific Ramfjord teeth

Change in Clinical Attachment Level (CAL)Baseline, 6 months, 12 months

Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.

Change in Gingival Margin Position (GM)Baseline, 6 months, 12 months

Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.

Number of participants with Supragingival and Subgingival CalculusBaseline, 6 months, 12 months

Recorded as present or absent, generalized or localized when visible or detected upon probing.

Change in Gingival Crevicular Fluid (GCF)Baseline, 6 months, 12 months

Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Kentucky🇺🇸 Lexington, Kentucky, United States

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